{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T09:20:39Z","timestamp":1761988839201},"reference-count":23,"publisher":"American Society for Microbiology","issue":"7","license":[{"start":{"date-parts":[[2015,7,1]],"date-time":"2015-07-01T00:00:00Z","timestamp":1435708800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2015,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>Analytical and clinical performance validation is essential before introduction of a new human papillomavirus (HPV) assay into clinical practice. This study compares the new BD Onclarity HPV assay, which detects E6\/E7 DNA from 14 high-risk HPV types, to the Hybrid Capture II (HC2) HPV DNA test, to concurrent cytology and histology results, in order to evaluate its performance in detecting high-grade cervical lesions. A population of 567 women, including 325 with \u2265ASCUS (where ASCUS stands for atypical cells of undetermined significance) and any HC2 result and 242 with both negative cytology and negative HC2 results, were prospectively enrolled for the study. The overall agreement between Onclarity and HC2 was 94.6% (95% confidence intervals [CI], 92.3% to 96.2%). In this population with a high prevalence of disease, the relative sensitivities (versus adjudicated cervical intraepithelial neoplasia grades 2 and 3 [CIN2+] histology endpoints) of the Onclarity and HC2 tests were 95.2% (95% CI, 90.7% to 97.5%) and 96.9% (95% CI, 92.9% to 98.7%), respectively, and the relative specificities were 50.3% (95% CI, 43.2% to 57.4%) for BD and 40.8% (95% CI, 33.9%, 48.1%) for HC2. These results indicate that the BD Onclarity HPV assay has sensitivity comparable to that of the HC2 assay, with a trend to an increased specificity. Moreover, as Onclarity gives the chance to discriminate between the different genotypes, we calculated the genotype prevalence and the absolute risk of CIN2+: HPV 16 was the most prevalent genotype (19.8%) with an absolute risk of CIN2+ of 77.1%.<\/jats:p>","DOI":"10.1128\/jcm.00246-15","type":"journal-article","created":{"date-parts":[[2015,4,23]],"date-time":"2015-04-23T02:41:05Z","timestamp":1429756865000},"page":"2109-2114","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":17,"title":["Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions"],"prefix":"10.1128","volume":"53","author":[{"given":"F.","family":"Bottari","sequence":"first","affiliation":[{"name":"Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Sideri","sequence":"additional","affiliation":[{"name":"Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Gulmini","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Igidbashian","sequence":"additional","affiliation":[{"name":"Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Tricca","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Casadio","sequence":"additional","affiliation":[{"name":"Diagnostic Cytology Unit, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Carinelli","sequence":"additional","affiliation":[{"name":"Department of Pathology, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Boveri","sequence":"additional","affiliation":[{"name":"Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Ejegod","sequence":"additional","affiliation":[{"name":"Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Bonde","sequence":"additional","affiliation":[{"name":"Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark"},{"name":"Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. T.","family":"Sandri","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.virol.2008.11.046"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-9896(199909)189:1<12::AID-PATH431>3.0.CO;2-F"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/dji186"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djq356"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1386-6532(09)70002-2"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2008.06.019"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/apm.12279"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62218-7"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.24010"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1309\/RNF3C01JKADQCLKP"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0463.2010.02621.x"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1586\/eri.10.104"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/path.4405"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.287.16.2140"},{"key":"e_1_3_2_16_2","volume-title":"WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention","author":"World Health Organization","year":"2013","unstructured":"World Health Organization. 2013. WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. World Health Organization, Geneva, Switzerland."},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2013.22"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1309\/AJCP53KMHNRDICBL"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.4172\/2161-0703.S3-003"},{"key":"e_1_3_2_20_2","first-page":"1394","article-title":"Restricted cross-reactivity of hybrid capture 2 with nononcogenic human papillomavirus types","volume":"11","author":"Castle PE","year":"2002","unstructured":"Castle PE, Schiffman M, Burk RD, Wacholder S, Hildesheim A, Herrero R, Bratti MC, Sherman ME, Lorincz A. 2002. Restricted cross-reactivity of hybrid capture 2 with nononcogenic human papillomavirus types. Cancer Epidemiol Biomarkers Prev 11:1394\u20131399.","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00824-08"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1386-6532(02)00187-7"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.34.9.2095-2100.1996"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2013.06.027"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.00246-15","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.00246-15","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,5]],"date-time":"2022-03-05T12:13:12Z","timestamp":1646482392000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/JCM.00246-15"}},"subtitle":[],"editor":[{"given":"Y.-W.","family":"Tang","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2015,7]]},"references-count":23,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2015,7]]}},"alternative-id":["10.1128\/JCM.00246-15"],"URL":"https:\/\/doi.org\/10.1128\/jcm.00246-15","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,7]]},"assertion":[{"value":"2015-01-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-04-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-06-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}